Menopause
Conditions
Keywords
Menopause, Hot flushes, Women's Health, Symptom Monitoring
Brief summary
A recent systematic review suggested that symptom monitoring can result in reductions in menopausal symptoms and improvements in health-related behaviours. To date, no studies have experimentally investigated whether symptom monitoring could be beneficial as an intervention for menopausal women. One hundred menopausal women were randomised into either a Monitoring-intervention or Control group. A mixed between/ within design was employed, with group membership (i.e., Monitoring-intervention or Control) as the between-subjects component, and time (i.e., baseline and 2-weeks follow-up) as the within-subjects component. Dependent variables included symptom reductions and emotional reactions. Secondary outcomes included help-seeking, communication, medical decision-making, health awareness, self-efficacy, and health anxiety.
Interventions
BEHAVIORALSymptom Monitoring
Reporting symptoms each day via a symptom questionnaire
Sponsors
University of South Wales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Women * Aged 18+ * Reporting at least 2 menopausal hot flushes per day * Self-reported peri- or post-menopausal status.
Exclusion criteria
* Male * Under age 18 * Reported fewer than 2 hot flushes per day * Does not self-report peri- or post-menopausal status.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menopausal symptom changes via the Daily Record Keeping (DRK) form | at baseline and after 2 weeks of symptom monitoring | Changes in menopausal symptom scores after 2-weeks of symptom monitoring, where reductions in symptoms would suggest a beneficial outcomes. |
| Emotional outcomes via the Daily Record Keeping (DRK) form | at baseline and after 2 weeks of symptom monitoring | Changes in emotion scores after 2-weeks of symptom monitoring. The DRK assesses emotional outcomes via specific emotion subscales including Negative Emotions, Positive affect, Anxiety, Depression, Loneliness. Reductions in Negative Emotions, Anxiety, Loneliness, Depression after 2-weeks would suggest benefical effects, as would increases in Positive Affect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decision making efficacy | at baseline after 2 weeks of symptom monitoring | Changes in Decision making efficacy scores as assessed via the Decision Self Efficacy (DSE) scale. Increases in DSE scores after 2-weeks would suggest benefical effects on medical decision making. |
| Health communication | at baseline after 2 weeks of symptom monitoring | Changes in Health communication scores as assessed via the Willingness to Communicate about Health (WTCH) questionnaire. Increases in WTCH scores after 2-weeks would suggest benefical effects on health communication. |
| Health Anxiety | at baseline and after 2 weeks of symptom monitoring | Changes in Health Anxiety scores as assessed via the Health Orientation Scale (HOS). Reductions in Health Anxiety after 2-weeks would suggest beneficial effects. |
| Help seeking intentions | at baseline and after 2 weeks of symptom monitoring | Changes in Help Seeking Intention scores as assessed via the General Help Seeking Questionnaire (GHSQ). Increases in GHSQ scores at 2-weeks would indicate benefical effects on help seeking behaviour. |
| Coping preference | Measured at baseline to assess whether coping preference moderated symptom monitoring outcomes | Monitoring/ Blunting Coping preference assessed via the Miller's Behavioural Style Scale (MBSS). The MBSS score can be used in analyses as a continuous variable, with individuals displaying more or less monitoring coping characteristics. Scores range from 0 (no monitoring characteristics) to 72 (high monitoring characteristics). |
| Trait neuroticism | Measured at baseline to assess whether trait neuroticism moderated symptom monitoring outcomes | Trait neuroticism was assessed via the IPIP-NEO 10-item neuroticism subscale. This scale ranges from 10 (low trait neuroticism) to 50 (high trait neuroticism). |
| Health Consciousness | at baseline and after 2 weeks of symptom monitoring | Changes in Health Consciousness scores as assessed via the HOS. Reductions in Health Consciousness scores after 2-weeks would suggest beneficial effects. |
| General Self Efficacy | at baseline and after 2 weeks of symptom monitoring | Changes in General Self Efficacy scores as assessed via the General Self Efficacy (GSE) scale. Increases in GSE scores at 2-weeks would indicate beneficial effects on self efficacy. |
Countries
United Kingdom
Outcome results
None listed